Project RAINBOW: patient monitoring in Inflammatory Bowel Disease
Research type
Research Study
Full title
Project RAINBOW: Real time data monitoring for patients with Inflammatory Bowel Disease
IRAS ID
266093
Contact name
Simon Travis
Contact email
Sponsor organisation
University of Oxford/Clinical Trials and Research Governance
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Project title: Project RAINBOW - Real time data monitoring for patients with inflammatory bowel disease.
Inflammatory bowel disease (IBD) includes three conditions: ulcerative colitis (UC), Crohn’s disease (CD) and inflammatory bowel disease-unclassified (IBD-U). All are lifelong conditions with no known cause. IBD follows an unpredictable course with intermittent periods of relapse and potentially severe symptom, with a significant impact on the patient's quality of life (QoL) and high lifetime costs associated with a patient's care.
Conventional management of IBD revolves around assessment during brief clinic visits several weeks/months apart. However, given the unpredictable nature of the disease, flares are often discordant from scheduled visits. Digital health data collection may enable more responsive care and enhance quality of care.
Patient-collected data using validated questionnaires also has the potential to streamline outpatient appointments for those most needing specialist care, maintain contact with patients, compare quality of life between hospitals or different treatment approaches among patients with similar demographics and to document patient reported outcomes such as hospital inpatient stays or steroid use. Streamlining outpatient appointments according to clinical need and the likelihood of a change in treatment for IBD, would optimise resource utilisation and requires a predictive tool. The Escalation of Therapy of Intervention (ETI) calculator was thus developed in the TrueColours pilot for patients with ulcerative colitis and now needs evaluating in practice.
Project RAINBOW is a randomised study which will allocate patients to either option A: TrueColours monitoring alongside routine clinical care, or option B: TrueColours monitoring used in a remote clinic, using the ETI calculator to determine whether a patient should be offered a deferred outpatient clinic appointment. TrueColours monitoring will involve daily symptom, fortnightly quality of life and three-monthly health outcomes questionnaires via email.
The study will take place at the John Radcliffe Hospital, Oxford, include 300 participants, aged 18+, for 36 months.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
20/SC/0101
Date of REC Opinion
20 Mar 2020
REC opinion
Favourable Opinion